Sat, 21 Feb 2004

Most drug companies fail to meet export standards, study says

Tony Hotland, The Jakarta Post, Jakarta

Only 10 percent of the country's 190 pharmaceutical companies have received the Current Good Manufacturing Practices (CGMP) certification for export, revealed a study by the Food and Drug Monitoring Agency (BPOM).

"If more companies fulfill CGMP conditions, our exports can increase and of course, this will have a positive impact on our pharmaceutical industry," BPOM head Sampoerno said on Friday during a discussion on the national pharmaceutical industry.

The CGMP is a BPOM certificate that assesses the "hardware and software" conditions of a pharmaceutical company and which gives license for a company to export its products. Those without CGMP certification can only sell to the domestic market.

The certification checks factors such as the conditions of a company's facilities, production process, stability of raw materials and human resource quality.

"For example, the design of a pharmaceutical factory should be circular to prevent dust and other pollutants from collecting in corners. The ratio of raw materials per gram or individual dose of a drug should be consistent," BPOM spokesperson Buddy Nataatmadja told The Jakarta Post.

Many companies are deterred from making an effort to obtain CGMP certification, said Buddy, because it required additional investment to improve equipment and because of the dual standard in the pharmaceutical trade.

The disparity between domestic and international drug standards meant that pharmaceutical companies could profit through domestic sales without investing extra capital on quality equipment and facilities necessary to meet international drug standards.

According to BPOM data, only 20 of the 190 companies have satisfactory hardware and software conditions, while 53 have minor flaws, 88 require repairs and 29 require major repairs.

Sampoerno said pharmaceutical exports last year made over US$100 million, an increase from $97.98 million in 2002.

He added that the sector should have a strategic orientation to develop its export potential. "Our goal is to seize a 30 percent global market share by 2010, up from the current 10 percent."

The chairman of the Indonesian Pharmaceutical Association (GPFI), Anthony Sunarjo, lamented Indonesia's low per capita drug expenditure.

"Our per capita drug expenditure stands at only $4.8. Compare that to the Philippines with $13.5, or Malaysia with $12.9."

Anthony, nevertheless, was optimistic that the pharmaceutical industry would advance in 2004, with a projected increase of 10 percent to 15 percent.

Economist Didik Rachbini from the Institute for Development of Economics and Finance, warned that the projection could only be realized if drug expenditures increased.

"We must improve the public's consumption rate to raise drug expenditures, and the consumption rate will only begin to pick up when the overall industry makes progress," said Didik.